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Section 510(k) clearance: while it doesn't support preemption, is it relevant evidence at trial?

With some courts, the § 510(k) clearance of a medical device is not only insufficient to support preemption. It’s not probative enough to be discussed at trial. The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device. According to a recent decision by one of the courts overseeing a trial on remand from the MDL, the MDL court read Medtronic v. Lohr to hold that § 510(k) clearance addresses only the device’s equivalence with an already marketed device, not safety. Winebarger v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 126616, at *13-14 (W.D.N.C. Sept. 22, 20150) (describing the basis for the MDL court’s decision).

We’re not so convinced. The 510(k) process is not a complete abandonment of safety considerations. And it certainly provides evidence of whether the manufacturer behaved reasonably. Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record. Moreover, the 510(k) process is an inescapable reality for device manufacturers. A discussion of the process, how it was followed, and the safety information that was provided or available through the marketing of equivalent devices is relevant to assessing the reasonableness of the manufacturer’s actions. If plaintiffs want to minimize its importance, establish that it says nothing about safety, or show what the manufacturer failed to do, they are free to present such evidence. The jury can then decide the relevance of this evidence.

Fortunately, the remand court, applying North Carolina law, got this right – sort of. In North Carolina, a jury may consider the “extent to which the design or formulation [of the device] conformed to any applicable government standard.” Winebarger, 2015 U.S. Dist. LEXIS, at *19 (quoting North Carolina’s Product Liability Act). And so, unlike the MDL court, the remand court determined that evidence of § 510(k) clearance is admissible. But introduction of that evidence will likely come with a fairly severe limiting instruction:

The fact that BSC followed the requisite 510(k) protocol – limited as it is – prior to marketing its Uphold device has minimal probative value regarding BSC's efforts to adhere to FDA processes and procedure generally. . . . Admissibility might depend upon a limiting instruction that 510(k) clearance is not to be considered as evidence that the FDA authorized the Uphold as safe and approved its intended use as such; that 510(k) clearance is not evidence that BSC satisfied any standard of care in designing the Uphold device. For these reasons, the Court's preliminary ruling on Plaintiff's motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order.

Id. at *22-23.

In other words, the Boston Scientific will be able to present evidence that it followed the 510(k) process and received clearance to market the product. But the court may then instruct the jury that such clearance is not evidence of the manufacturer satisfying a standard of care.

That presents a tricky decision for Boston Scientific. Should it present this evidence to the jury knowing that it will be met with this severe limiting instruction? It seems to us that this evidence is probative, even if not determinative, of whether Boston Scientific satisfied its standard of care. It’s certainly probative of whether Boston Scientific acted reasonably. North Carolina’s Product Liability Act makes that clear. It authorizes juries to consider whether a manufacturer met any governmental standard when determining the reasonableness of its actions. N.C. Gen. Stat. § 99B-6(a) & (b).

Frankly, this seems like a decision that Boston Scientific should not be forced to make. If the plaintiffs want to undermine the significance of 510(k) clearance, they can do so by presenting their own evidence and experts, and by cross-examining Boston Scientific’s witnesses. It’s a whole other ballgame, though, for the court to interject and describe the evidence, telling the jury that it is not probative of whether Boston Scientific met its standard of care. That seems to verge on undermining the mandate of the statute, which leaves that determination to the jury.